Incentive Spirometer and Inspiratory Muscle Trainer

January 27, 2022 updated by: Masood Khan, King Saud University

A Comparative Study of Incentive Spirometer Versus Inspiratory Muscle Trainer on Pulmonary Function in Patients With Parkinsonism

Patients suffering from parkinsonism have respiratory function abnormalities. This study compared the effects of incentive spirometer and inspiratory muscle trainer on pulmonary functions in patients with parkinsonism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participants were recruited according to the inclusion and exclusion criteria. Participants were divided into two groups - incentive spirometer and inspiratory muscle trainer. These trainings were performed for 6 weeks duration. Several outcome measures related to pulmonary function tests were measured before and after the intervention.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11433
        • King Saud university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 75 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients diagnosed as having Parkinsonism Disease by the Neuro physician.
  • Duration of Parkinson's Disease ≥ 5 years.
  • Patients with the age of 65 to 80 years.
  • Hoen and Yahr classification within 1 to 3.
  • Both males and females were included.
  • Patients who were able to comprehend the commands.
  • Patients who were willing to participate.

Exclusion Criteria:

  • Patients having any cardiovascular and pulmonary disorders.
  • History of smoking currently or in the past.
  • Psychological Impairment.
  • Insufficient verbal/intellectual understanding.
  • Patients with unstable vital parameters.
  • Those unable to perform pulmonary function tests (PFT) because of anatomical abnormalities or clinical signs of dementia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Inspiratory muscle trainer
Inspiratory muscle trainer group - Inspiratory muscle training was performed.
Other: Inspiratory muscle training
Threshold inspiratory muscle training was performed for 6 weeks with device.
Active Comparator: Incentive spirometer
Incentive spirometer group - Incentive spirometry was performed.
Other: Incentive Spirometry
Incentive spirometry was performed for 6 weeks with device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum inspiratory pressure (MIP)
Time Frame: 6 weeks
Maximum inspiratory pressure was measured.
6 weeks
6-minute walk distance (6 MWD)
Time Frame: 6 weeks
Distance walked by the patients in 6 minutes was measured.
6 weeks
Forced vital capacity (FVC)
Time Frame: 6 weeks
Forced vital capacity was measured.
6 weeks
Forced expiratory volume in 1 second (FEV1)
Time Frame: 6 weeks
Forced expiratory volume in 1 second was measured
6 weeks
Peak Expiratory Flow Rate (PEFR)
Time Frame: 6 weeks
Peak Expiratory Flow Rate was measured
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Saud University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 6, 2017

Primary Completion (Actual)

January 18, 2018

Study Completion (Actual)

May 10, 2018

Study Registration Dates

First Submitted

January 9, 2022

First Submitted That Met QC Criteria

January 9, 2022

First Posted (Actual)

January 21, 2022

Study Record Updates

Last Update Posted (Actual)

February 10, 2022

Last Update Submitted That Met QC Criteria

January 27, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GSITESC/24/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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